Tetanus Clinical Trial
Official title:
Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age
The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10
years of age.
Primary Objectives:
- To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years
of age to those induced by Adacel in persons 11 to <12 years of age.
- To compare the booster responses against pertussis antigens induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.
- To compare booster responses against tetanus and diphtheria induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.
Secondary Objective:
- To compare seroprotection rates against tetanus and diphtheria induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.
Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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